NL-OMON52276招募中2 期
A proof of concept phase II study with the PDE4 inhibitor roflumilast in people suffering from long-term cognitive sequela after stroke - Roflumilast to treat cognitive sequelae after stroke
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-41 to 70 years of age;
- •-willingness to sign an IC;
- •-Objective cognitive complaint: memory performance on the delayed recall in the
- •15 words VWLT below the normative score (corrected for education, sex and age)
- •(see Van der Elst, van Boxtel, van Breukelen, & Jolles, 2005).
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participating in this study: Normal Pressure Hydrocephalus (NPH), Morbus
- •Huntington, Parkinson's disease, HIV/AIDS and Hepatitis B and C, recent
- •Transient Ischemic Attack (TIA), COPD Gold 3 and 4, history of schizophrenia,
- •bipolar disorder or psychotic symptoms not otherwise specified or previous
- •treatment for these diseases (lifetime), current affective disorder (i.e.
- •anxiety or major depression), cognitive problems due to alcohol abuse, brain
- •tumor, epilepsy, encephalitis or lack of capacity to consent to participation.
- •Other exclusion criteria are current treatment with (or illicit use of)
- •cannabis, opiates, benzodiazepines, Methylenedioxymethamphetamine (MDMA) and
- •cocaine. Roflumilast is contraindicated in patients with moderate to severe
- •liver impairment, accordingly patients with moderate or major liver impairments
- •will be excluded (e.g. Child-Pugh B and C). Use of medication showing strong
- •inhibition of either CYP3A4 (e.g. clarithromycin, antihistamines) or CYP1A2
- •(e.g. fluvoxamine, ciprofloxacin and other fluoroquinolones) is also an
- •exclusion criterion because of interference with roflumilast metabolism
- •resulting in reduced therapeutic effectiveness of roflumilast. Individuals with
- •rare hereditary problems of galactose intolerance, Lapp lactase deficiency or
- •glucose-galactose malabsorption will be excluded, as both the placebo and
- •roflumilast contain lactose monohydrate. Additionally, during the period of the
- •present study, participants are not allowed to participate in other drug
研究者
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